Articles from EvoEndo, Inc.

EvoEndo®, Inc. (EvoEndo) announces that the EvoEndo® Model LE Gastroscope is now FDA-cleared for patients of all ages — from neonates to adults. Since 2022, the EvoEndo System has been the only option available for sedation-free transnasal endoscopy for pediatric patients five and older. Now, the expanded indication makes safe, transoral endoscopy available to infants and young children, a previously underserved population. In just three years, EvoEndo has redefined what’s possible – and who it’s possible for.

EvoEndo®, Inc. (EvoEndo) is excited to announce the release of the Model LE 85 Single-Use Gastroscope, providing an additional option for Sedation-Free Transnasal Endoscopy (TNE) of the Upper Gastrointestinal Tract.

EvoEndo®, Inc. (EvoEndo) announces that Duke Health is the first provider in the region to bring Sedation-Free TNE (Transnasal Endoscopy) of the Upper Gastrointestinal (GI) Tract using the EvoEndo® Single-Use Endoscopy System to patients (five and older) in North Carolina.

EvoEndo®, Inc. (“EvoEndo”) is proud to announce it continues to expand access to sedation-free TNE (Transnasal Endoscopy), making this vital, safer alternative available to more children nationwide.

EvoEndo®, Inc. (“EvoEndo”), announces that Matthew J. Ryan, MD, pediatric gastroenterologist, is the first physician in the nation to complete more than 100 TNEs (Transnasal Endoscopies) of the Upper Gastrointestinal (GI) Tract using the EvoEndo® Single-Use Endoscopy System, cleared for use in patients five and older without anesthesia or sedation.

EvoEndo®, Inc. (“EvoEndo”), a medical device company developing platforms for Unsedated Transnasal Endoscopy (TNE), is proud to announce that David Pierce has joined our Board of Directors.

EvoEndo®, Inc. (“EvoEndo”), a medical device company developing systems for unsedated Transnasal Endoscopy (TNE), is pleased to announce that Children’s Hospital Los Angeles (CHLA) is the first care center in California to use the EvoEndo® Single-Use Endoscopy System to perform a diagnostic unsedated TNE of the Upper Gastrointestinal (GI) Tract. CHLA is the largest provider of care for children in Los Angeles County and, according to U.S. News & World Report’s 2022-23 Best Children’s Hospitals list, the top-ranked children’s hospital in California and the Pacific U.S. region.

EvoEndo®, Inc. (“EvoEndo” or the “Company”), a medical device company developing platforms for Unsedated Transnasal Endoscopy (TNE), today announced key leadership changes.

EvoEndo®, Inc. (“EvoEndo”), a medical device company developing systems for Unsedated Transnasal Endoscopy (TNE), is pleased to share recent decisions announced by the Centers for Medicare and Medicaid Services (CMS) in its CY 2023 Hospital Outpatient Prospective Payment System (OPPS) final rule. Based on information submitted to CMS including the cost of the EvoEndo Model LE Single-Use Gastroscope and its recent 510(k) FDA clearance, CMS decided to modify the APC assignments for CPT codes 0652T, 0653T and 0654T. Effective July 1, 2023, the APC assignment for CPT 0652T (transnasal diagnostic EGD) and 0653T (transnasal EGD with biopsy) will change from APC 5301 (Level 1 Upper GI Procedures) to APC 5302 (Level 2 Upper GI Procedures). Additionally, CPT 0654T (transnasal EGD with insertion of intraluminal tube or catheter) will be moved from APC 5302 (Level 2 Upper GI Procedures) to APC 5303 (Level 3 Upper GI Procedures).1

EvoEndo®, Inc. (“EvoEndo”), a medical device company which developed a single use system that allows for unsedated Transnasal Endoscopy (TNE), has announced the completion of an $8.4 million Series A financing round led by founding investor TLP Investment Partners LLC (TLP) and including the Sunshine Charitable Foundation and the Jill and Paul Meister family. Proceeds from the financing will be used to support the initial commercial launch of the EvoEndo® Single-Use Endoscopy System by hiring additional personnel and growing inventory capacity. The company will also deploy the funding to conduct clinical and post-market surveillance studies.

EvoEndo®, Inc. (“EvoEndo”), a medical device company developing systems for unsedated endoscopy, today announced the signing of a distribution agreement with Micro-Tech Endoscopy USA, Inc. (“Micro-Tech”). The agreement, whereby Micro-Tech will distribute the EvoEndo® Single-Use Endoscopy System in the U.S., is expected to begin pending U.S. FDA 510(k) clearance.

EvoEndo® Inc., (“EvoEndo” or “the Company”) a preclinical medical device company developing systems for unsedated Transnasal Endoscopy (TNE), announced it has secured $10.1M in equity financing. The funding round, which included a variety of family offices and early-stage life science investors, will be used to further EvoEndo’s innovative technology designed to help physicians diagnose, treat, and monitor conditions for a variety of gastrointestinal disorders.